Study of Toripalimab After Chemoradiotherapy in Older Adults With Locally Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the use of toripalimab, an anti-PD-1 antibody, after chemoradiotherapy for elderly patients with locally advanced esophageal squamous cell carcinoma ESCC who cannot have surgery. The study aims to improve survival and reduce recurrence, as many elderly patients have difficulty tolerating intravenous treatments and have a high rate of cancer returning after standard chemoradiotherapy. This phase II trial seeks to find a safer, more effective treatment option for patients aged 70 to 85 years. Patients will receive a combination of radiotherapy and oral S-1 chemotherapy concurrently. Then, participants are randomly assigned to either receive toripalimab as a consolidation therapy for up to 12 months 16 cycles or to undergo routine follow-up without additional treatment. The radiotherapy is delivered as 54 Gy over 27 fractions in 5 to 6 weeks using intensity-modulated radiotherapy. The study compares outcomes between those receiving toripalimab and those who do not after completing chemoradiotherapy. Participants will be closely monitored through regular follow-ups for up to 36 months, with assessments including progression-free survival, overall survival, clinical response 13 to 16 weeks after radiotherapy, duration of response, and treatment-related side effects. Researchers will evaluate the safety and effectiveness of adding toripalimab to standard therapy, with the goal of improving long-term control of esophageal cancer in elderly patients. The total observation period includes up to three years from enrollment for outcome evaluation.

Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007)